Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
50041–50064 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 2010
JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136
K100287 · NXD
U.S. Army Medical Material...
Microbiology · 158d
Cleared Jul 06, 2010
ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM
K100728 · LSR
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Jul 06, 2010
6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND...
K101195 · DJG
Lin-Zhi International, Inc.
Chemistry · 68d
Cleared Jul 06, 2010
NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED...
K101736 · FLL
Shenzhen Everbest Machinery Industry...
General Hospital · 15d
Cleared Jul 02, 2010
BONE PLUS BCP
K090950 · LYC
Megagen Implant Co., Ltd.
Dental · 455d
Cleared Jul 02, 2010
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
K092859 · CAF
Merits Health Products Co., Ltd.
Anesthesiology · 288d
Cleared Jul 02, 2010
ACTIPROTECT UC N95 RESPIRATOR
K093189 · ORW
Glaxosmithkline Consumer Healthcare
General Hospital · 266d
Cleared Jul 02, 2010
KMD-MARK1 TISSUE MARKER
K093473 · NEU
Kent Medical Devices, Inc.
General & Plastic Surgery · 238d
Cleared Jul 02, 2010
MEDLINE PVC URETHRAL CATHETER
K100302 · EZD
Medline Industries, Inc.
Gastroenterology & Urology · 149d
Cleared Jul 02, 2010
PROTOE ENDOSORB SMALL HAMMER TOE PIN
K100414 · JDW
Merete Medical GmbH
Orthopedic · 136d
Cleared Jul 02, 2010
EVIS EXERAII 180 SYSTEM
K100584 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 122d
Cleared Jul 02, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
K100620 · DXN
Harvard Medical Devices , Ltd.
Cardiovascular · 120d
Cleared Jul 02, 2010
NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE,...
K100979 · LZA
Jiangsu Sunshine Plastic Products,...
General Hospital · 85d
Cleared Jul 02, 2010
DSS STABILIZATION SYSTEM
K101083 · NQP
Paradigm Spine, LLC
Orthopedic · 74d
Cleared Jul 02, 2010
ELI 250 ELECTROCARDIOGRAPH
K101403 · DPS
Mortara Instrument, Inc.
Cardiovascular · 44d
Cleared Jul 02, 2010
MD VISION SYSTEM
K101474 · DXJ
Perkins Healthcare Technologies
Cardiovascular · 35d
Cleared Jul 02, 2010
CHEETAH NICOM SYSTEM
K101487 · DXG
Cheetah Medical, Inc.
Cardiovascular · 35d
Cleared Jul 02, 2010
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL...
K101667 · DQK
St Jude Medical
Cardiovascular · 18d
Cleared Jul 02, 2010
MISTRAL-AIR WARMING SYSTEM
K101705 · DWJ
The Surgical Company International B.V.
Cardiovascular · 15d
Cleared Jul 01, 2010
ANTI-MUTATED CITRULLINATED VIMENTIN EIA
K092399 · OQZ
Orgentec Diagnostika GmbH
Immunology · 329d
Cleared Jul 01, 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
K093877 · DYB
Edwards Lifesciences, LLC
Cardiovascular · 197d
Cleared Jul 01, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
K100059 · LYZ
Tangshan Zhongpu Plastic Products...
General Hospital · 174d
Cleared Jul 01, 2010
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON,...
K100275 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 150d
Cleared Jul 01, 2010
SYNTHES MATRIX SYSTEM
K100634 · NKB
Synthes (Usa)
Orthopedic · 118d